The following is offered as background information only and is not admitted to be prior art to the present invention.
Cancer is one of the most common diseases affecting humankind, and is a leading cause of death worldwide. In the United States alone, it is the second leading cause of death, behind coronary disease.
Aging in an organism is accompanied by an accumulation of changes over time. It is a multifactorial process resulting in the progressive deterioration of organ systems and bodily tissues. Aging is the result of both genetic and environmental factors including diet, exercise, microorganism exposure, chemical pollutants and natural and manmade radiation exposure. (Nigam Y, et al., J. Aging Research, Vol. 2012, Art. ID No. 468469.) Aging is comprised of three groups of changes including: changes in homeostatic mechanisms such as body temperature, blood, and extracellular fluid volumes; decrease in organ mass; and a decline in/loss of the bodily systems' reserves. The latter change is thought to coincide with impairment of the ability to adjust to external challenges like surgery or other types of trauma. The challenge is to maintain the health of the world's aging population to maintain quality of life as well as to reduce the burden on the medical infrastructure. (See id.)
Cancer frequently accompanies aging and is a disease of uncontrolled cellular growth. In fact, the single greatest risk factor for developing cancer is aging. More than 60% of cancers in the United States occur in people age 65 and older.
Cancer is considered to comprise six hallmarks: (1) sustaining proliferative signaling; (2) evading growth suppressors; (3) activating invasion and metastasis; (4) enabling replicative immortality; (5) inducing angiogenesis; and (6) resisting cell death. (Hanahan D., et al., Cell Vol. 144, (2011) pp. 646-74). Over the past several decades, various cancer treatments have arisen to counter these processes. For example, cancer is usually treated by one or more of the following: surgery, chemotherapy (including small molecule therapy directed towards specific targets), radiation therapy, immunotherapy, and monoclonal antibody therapy. The location and grade of the tumor as well as the stage of the disease usually determines the type of therapy applied. Although measurable progress has been made since a “War on Cancer” was declared over four decades ago, there exists a need for new therapies, particularly therapies with natural bases with the ability to raise quality of life, improve compliance, and produce less side effects than those exhibited by previous cancer therapies.
It has been observed that cancer and autoimmunity share a bidirectional relationship. (Tal Sapir, et al., Uncovering the Hidden Potential of Intravenous Immunogloblin as an Anticancer Therapy, 29 Clin. Rev. Allergy & Immunology 307 (2005), herein incorporated by reference). Accordingly, administration of intravenous immunoglobulin (commonly abbreviated as IVIg, IVIG or IGIV), a preparation from human plasma, has been reported to have certain observable effects on cancer regression. (Id.) This autoimmune function is thought to be mediated via the effects IVIg has upon the subject's T-cells. (Jagadeesh Bayry, et al., Intravenous Immunoglobulin Expands Regulatory T Cells in Autoimmune Rheumatic Disease, 32 J. Rheumatology 450 (2012), herein incorporated by reference).